Elevating Quality Standards Across the Enterprise and Partner Network

Precision medicine and the rise of more complex business models based on outsourcing and growth through acquisition have thrust quality management into a more visible and strategic role. Instead of just focusing on regulatory compliance and reacting to individual issues, quality teams are adopting a proactive, predictive mindset to drive business success.

“Today, we’re expected to drive operational excellence and innovative thinking, so we’re developing a true partnership with the business side, offering agile processes and technology solutions,” says Nicholas Maldonado, executive director of global quality systems and compliance at Gilead Science.

New treatment modalities such as mRNA, antibody-drug conjugates, and cell therapies are redefining biopharma manufacturing, resulting in new learning and training strategies. Meanwhile, as companies participate in more mergers and acquisitions, and increase the use of outsourcing, they need to rethink the way they are managed.

At the same time, quality teams must respond to changing workforce demographics and the needs of a generation that was raised in a fully digital experience. “Younger quality professionals learn and seek information in different ways and expect systems at work to function on par with smartphones and technology at home,” Maldonado comments. As a result, Gilead has been rethinking the way it structures quality learning and training and shifting from a ‘know-it-all’ culture to a ‘find-it-all’ employee experience.

Outsourcing 75-80% of its manufacturing and testing, Gilead needed to evolve its business strategies and standardize quality processes to seamlessly share information, not only with acquired companies but with outsourcing partners.

Standardizing practices with the acquired companies

Since its launch in 1987, the company acquired several firms, with Kite Pharma and Immunomedics being the most notable recent additions.

After the acquisition, Gilead integrated and standardized quality data and documentation at the earliest stages. This approach worked particularly well with Kite Pharma and Immunomedics, strengthening its presence in oncology markets.

When it acquired Kite, for example, Gilead was finalizing the configuration for its quality document management systems (QDMS). Kite needed to speed the expansion of its European manufacturing capacity, so Maldonado and his team expanded the QDMS rollout plan to include Kite’s European business.

During the COVID-19 pandemic, Gilead migrated Vault QualityDocs, QMS records, and training, integrating them into Immunomedics’ systems. The effort boosted efficiency by enabling both companies to share information, develop specs, and improve test methods.

Working more efficiently with contract partners

To improve data management and external collaboration, Gilead implemented Vault QualityDocs, which helped the company optimize data sharing and exchange strategies with its growing number of contract partners.

“Collaboration with Veeva allowed us to grow our supply chain network while increasing control and agility. It eliminated any confusion about communication and data exchange practices and gave partners instant access to the latest versions of relevant Gilead documentation,” Maldonado says.

The results include better collaboration and partner relations, reduced cycle times for data review, and improved visibility into sources of risk. “Not only has it improved response times for closing out issues, but it has also ensured compliance by improving the quality of data,” he adds.

Improvements were visible during the pandemic when Gilead had to increase production of its antiviral agent, Remdesivir (Veklury). New approaches helped the company expand to meet public health emergency needs. Within three months, Gilead trained and onboarded seven new partners. Subsequently, it expanded global operations with 11 more partners.

As the use of outsourcing increases, so does the need for greater transparency and knowledge sharing. Maldonado predicts this type of sponsor-contractor partnership to become the industry standard in the future. Success depends on a strong foundation in which both partners benefit from closer connection, along with better communication and aligned expectations. Increased use of data trends and reports can also help third-party partners manage day-to-day business and regulatory activities.

Vault plans and best practices

Gilead standardized its quality information in Veeva Vault Quality platform, starting with QualityDocs and QMS. It’s also using Vault Quality to RIM Connection to streamline the data flow from regulatory affairs to quality in batch release change control. This process is usually addressed with disconnected data and manual processes, which can lead to drug shortages and delays in drug availability.

Maldonado reports that bringing quality and regulatory cultures together as early as possible has been key to its progress, along with the establishment of clear governance based on each team member’s ability to perform the job at hand. “Be sure to treat integration as an end-to-end process, rather than a handoff from one team to the other,” he advises.

In any quality modernization project, a focus on change management is essential to bringing the whole organization along and requires active workplace participation at every stage. Maldonado suggests investing in structured organization change management, whatever the size of your company or stage of your improvement efforts; “It will pay great dividends [by speeding] user adoption.”

Visit Veeva Connect (starts at 13:00 min) to hear Maldonado’s full fireside chat at Veeva’s 2023 R&D and Quality Summit.

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